RCT Results: Is Weight Loss Maintained After Discontinuing Use of Tirzepatide?
BACKGROUND AND PURPOSE:
Previous trials have demonstrated the efficacy of tirzepatide, a once-weekly injectable GLP-1 receptor agonist, for the treatment of obesity and overweight with or without diabetes
Over 72 weeks, mean reduction of body weight was up to approximately 20%
Aronne et al. (JAMA, 2023) assess the effect of tirzepatide withdrawal on the maintenance of weight reduction
Phase 3, randomized withdrawal clinical trial
Adults with a BMI ≥30 or
≥ 27 and a weight-related complication
36 weeks once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide, followed by
Continuation for 52 weeks
Switch to placebo
All patients received diet and exercise counseling
Mean percent change in weight from week 36 to week 88
Proportion of participants at week 88 who maintained at least 80% of the weight loss during lead-in
Mean age: 48 years | Women: 71% | Mean weight: 107.3 kg
Mean weight reduction in 36-week lead-in: 20.9%
From week 36 to week 88, there was a significant difference in mean percent weight change among the continuation and placebo cohorts
Continuation: –5.5% | Placebo: 14.0%
Difference –19.4% (95% CI, –21.2 to –17.7) | P<0.001
A greater proportion of patients in the continuation cohort maintained at least 80% of the lead-in weight loss, compared to the placebo cohort
Continuation: 89.5% | Placebo: 16.6% | P<0.001
Overall mean weight reduction from week 0 to 88
Most common adverse events
Mild to moderate gastrointestinal events
Participants with overweight and obesity who received placebo after 36 weeks of tirzepatide experienced substantial weight regain
Participants who continued tirzepatide maintained the initial weight loss, and even furthered improved their weight
The authors state
At least 5 trials (including the present study) across various classes of medications, including potent antiobesity medications such as semaglutide, have demonstrated that weight is substantially regained after cessation of pharmacotherapy
The consistency of these data across therapeutic classes spanning more than 2 decades suggests that obesity is a chronic metabolic condition similar to type 2 diabetes and hypertension requiring long-term therapy in most patients
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